FDA Won't Regulate "General Wellness" Products

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) has released final guidance stating that it does not intend to regulate low-risk, "general wellness" products that promote a healthy lifestyle, including personal fitness trackers, sleep monitors, and associated mobile apps.

FDA defines a "general wellness" product as one with (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity (that do not make reference to a disease or condition), or with (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions, and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

With these definitions, FDA has kept in line with its previous guidance on other health and wellness products — such as mobile medical applications and exercise equipment — where the product could be subject to FDA regulation depending on its intended use, according to RAPS.

Examples in the first category of general wellness products include those dealing with weight management, physical fitness, or sleep management, with claims like maintaining healthy weight, improving fitness by logging exercise activity, or promoting sleep hygiene by tracking sleep trends. However, claims that a product will, for example, treat obesity, muscle atrophy, or an anxiety disorder, do not qualify as a "general wellness" claim, because they refer to a particular disease or condition.

However, the second category of wellness products allows companies to refer to diseases or conditions if the intended uses are part of a healthy lifestyle that may help reduce the risk of such diseases or conditions, or help people live well with certain chronic conditions.

"The claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are described in peer-reviewed scientific publications or official statements made by healthcare professional organizations," FDA states in the final guidance. "Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or help in living well with that disease include heart disease, high blood pressure, and type 2 diabetes."

FDA says it will not regulate products that fall under the two aforementioned categories of general wellness products. It clarified, however, that the product should also be deemed low-risk, meaning it is not invasive, implanted, or involves technology or intervention that poses a risk to users or others. For example, a neurostimulation device that claims to improve memory, but poses a risk to the user due to electrical stimulation, will not be considered a general wellness device, and likely will be regulated by the Center for Devices and Radiological Health (CDRH), especially if precedent has been set by similar products.

In the final guidance, FDA provides several examples of low-risk general wellness devices that will not fall under its regulatory purview.

One is a mobile application that solely monitors and records daily energy expenditure and cardiovascular workout activities to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health."

"This claim relates to a specific organ only in the context of general health and does not refer to a disease or medical condition. In addition, although the monitoring or recording of exercise activities present risks (such as inaccuracy), when made in the absence of disease or medical condition claims, the technology does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low risk general wellness product," states FDA.

Another example is a portable product intended to monitor the pulse rate of users during exercise and hiking, a regular feature of many fitness trackers and wearables in the consumer market.

"This claim relates only to exercise and hiking and does not refer to a disease or medical condition. Thus, it is a general wellness claim. In addition, the technology for monitoring pulse rate does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low-risk general wellness product," explains FDA.